This phase I trial studies the side effects and best dose of stereotactic body radiation therapy after induction chemotherapy in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes and cannot be removed by surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Radiation therapy after chemotherapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02873598.
PRIMARY OBJECTIVE:
I. To identify the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in locally advanced pancreatic cancer (LAPC) patients who have not developed distant progression after following induction chemotherapy (fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin [FOLFIRINOX] or gemcitabine and nab-paclitaxel as per standard of care).
SECONDARY OBJECTIVES:
I. To preliminarily assess the 2-year local control, progression free and overall survival rates for LAPC patients after induction chemotherapy and SBRT.
II. To identify early changes in the normal small intestine after SBRT for LAPC using perfusion computed tomography (CT) derived parameters to document changes in tissue perfusion kinetics and heterogeneity that predict for development of gastrointestinal toxicity such as duodenal ulcers, strictures, or enteritis.
III. To investigate vascular and cellular changes resulting from SBRT for LAPC using perfusion CT derived parameters that can predict treatment response and to assess any correlation between these perfusion CT derived parameters and local control and progression-free survival.
IV. Evaluate quality of life (QOL) in terms of global QOL, physical symptoms, physical functioning and emotional well-being after induction chemotherapy and SBRT.
OUTLINE: This is a dose-escalation study.
Within 2-8 weeks after induction chemotherapy, patients undergo SBRT for 3 fractions every other day in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 and 10-12 weeks, at 6, 9, and 12 months, every 6 months for 3 years, and then annually thereafter.
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorSana D Karam